Samsung Expands Global Reach of Sleep Apnea Feature on Galaxy Watch With CE Marking Certification in Europe
SEOUL, Korea – June 5, 2025 – Samsung Electronics Co., Ltd. today announced that the Sleep Apnea feature1 on the Galaxy Watch series, available through the Samsung Health Monitor app2, is officially expanding its availability to include 34 European markets3, Australia and Singapore, increasing the global total to 70 markets4.
This growth has been driven by the feature securing CE (Conformité Européenne, European Conformity) marking for the European Economic Area (EEA). The CE marking affirms that Samsung meets the European Union's strict health, safety, and environmental protection standards, further solidifying its leadership in sleep technology. Additionally, the feature has recently been approved by the Therapeutic Goods Administration (TGA) in Australia and Health Sciences Authority (HSA) in Singapore.
The milestone follows Samsung’s groundbreaking United States Food and Drug Administration (FDA) De Novo authorization — the first of its kind for a wearable device to detect signs of moderate to severe obstructive sleep apnea. Moreover, the Sleep Apnea feature has also received regulatory approval from Korea’s Ministry of Food and Drug Safety (MFDS), Brazil’s Health Regulatory Agency (ANVISA) and Health Canada, Canada's regulatory authority.
Recognizing the critical role of sleep in overall health, Samsung is committed to enhancing users’ sleep quality by understanding their sleep patterns, providing personalized sleep coaching and optimizing sleep environments. The Sleep Apnea feature on Galaxy Watch now enables even more users to identify possible symptoms earlier — helping to prevent health issues associated with this common yet often undiagnosed condition.
When it comes to your health, small changes can make a big difference, starting with a good night’s sleep. The quality of sleep we get every night has a significant impact on our physical and mental well-being, and the Sleep Apnea feature continues Samsung’s commitment to provide Galaxy users with the best possible tools to improve healthy sleep habits. By expanding access to its Sleep Apnea feature globally, Samsung is empowering users worldwide to take proactive steps toward better sleep health.
About Samsung Electronics Co., Ltd.
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1 The Sleep Apnea Feature is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and phone. This feature is intended to detect signs of moderate to severe obstructive sleep apnea in the form of significant breathing disruptions in adult users aged 22 and older, over a two-night monitoring period. It is intended for on-demand use. This feature is not intended for users who have previously been diagnosed with sleep apnea. This feature should not be used to replace traditional methods of diagnosis and treatment by a qualified clinician. The data provided by this device is also not intended to assist clinicians in diagnosing sleep disorders.
2 Availability may vary by market, carrier, model, or a paired smartphone. Available on Galaxy Watch4 series and later models. The watch requires the Wear OS 5.0 version or later and must be paired with a Samsung Galaxy smartphone with Android 12.0 or later. Due to market restrictions in obtaining approval/registration as a Software as a Medical Device (SaMD), it only works on watches and smartphones purchased in the markets where service is currently available (however, service may be restricted when users travel to non-service markets).
3 In some European markets, the application dates may vary according to national registration.
4 Supported markets include Australia, Austria, Azerbaijan, Bahrain, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, Christmas Island, Cocos (Keeling) Islands, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Finland, France, Georgia, Germany, Greece, Guatemala, Hong Kong, Hungary, Iceland, Ireland, Italy, Kuwait, Latvia, Lithuania, Luxembourg, Malta, Mauritius, Mayotte, Mexico, Netherlands, Nicaragua, Norfolk Island, Norway, Oman, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Réunion, Slovakia, Slovenia, South Africa, South Korea, Singapore, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom, United States, Venezuela, Vietnam, Yemen.